A mind-bending hallucinogen is moving out of the counterculture and into the clinic.
The Food and Drug Administration on Friday greenlit the first-ever human clinical trial of an ibogaine derivative in the US, opening the door to testing the psychedelic drug as a potential treatment for alcohol-use disorder.
The move comes just days after President Donald Trump signed an executive order aimed at fast-tracking psychedelic research and expanding access for people struggling with mental illness.
“These medications have the potential to address the nation’s mental health crisis,” FDA Commissioner Marty Makary said in a press release.
“As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence.”
In a related push, the FDA also awarded national priority vouchers to three companies developing psychedelic treatments for major depressive disorder and PTSD, a move expected to speed up the agency’s review process.
Interest in ibogaine has surged in recent years, backed by a growing list of high-profile figures, including former Texas Gov. Rick Perry, former Sen. Kyrsten Sinema and podcast host Joe Rogan, who personally urged Trump to loosen restrictions on the drug.
Supporters believe the drug could be a powerful tool for treating addiction, PTSD and traumatic brain injuries, especially among military veterans. Here’s everything you need to know.
What is ibogaine?
It’s a naturally occurring psychoactive compound found in the root bark of the iboga shrub, native to Central and West Africa, according to the UC Berkeley Center for the Science of Psychedelics.
For centuries, tribal communities have used ibogaine in religious, spiritual and healing ceremonies, where it is said to induce hallucinations and foster a sense of connection to ancestors and others.
In France, the substance was sold for more than three decades as a stimulant and antidepressant, until it was banned by the government in the 1960s.
Around that same time, researchers began taking a closer look at ibogaine for its potential anti-addictive effects, after anecdotal reports from heroin users in the US claimed it reduced cravings and eased withdrawal symptoms.
What are the effects of ibogaine?
Once taken — typically in capsule form or as powdered root bark mixed with water — ibogaine triggers long-lasting psychedelic and dissociative effects.
In the first few hours, users often describe what feels like a dream-like “trip,” marked by vivid, sometimes intense visions. That’s usually followed by a deeply introspective phase that can stretch on for hours or even days.
During this period, the brain is believed to become more flexible, allowing it to form new connections, according to Dr. Kirsten Cherian, a researcher at Stanford University who led a landmark study on ibogaine.
“It acts across multiple neurotransmitter systems,” she told CNN, noting that its effects more intense than other psychedelics, like PTSD. “That’s contributing to sort of reorganizing brain networks.”
Researchers say these neurological shifts may help explain some of the reported benefits seen in treatment settings.
What are the potential benefits?
Much of the buzz around ibogaine centers on its potential to ease withdrawal symptoms and curb cravings for opioids, cocaine and alcohol. Still, clinical research on the drug remains limited.
In a 2017 study, researchers administered a 12 mg/kg dose of ibogaine to 30 participants with opioid dependence and tracked their progress for a year.
One month after treatment, half of the participants reported no opioid use. At the 12-month mark, seven said they had continued to stay off the drugs.
In another study, 80% of people who received ibogaine treatment in Mexico reported that it eliminated or sharply reduced their opioid withdrawal symptoms. Half said it reduced cravings, and 30% reported they never used opioids again.
Other research has also suggested ibogaine may have potential benefits for depression, anxiety and traumatic brain injuries, among other mental health conditions.
What are the risks?
Ibogaine is generally believed to have a low risk of addiction, but experts warn it can be dangerous.
Side effects may include low blood pressure, seizures, difficulty breathing, anxiety and hallucinations.
The drug is also known to cause irregular heart rhythms and has been linked to more than 30 deaths in the medical literature, according to the Multidisciplinary Association for Psychedelic Studies.
“This drug must be taken in a medical facility with the appropriate training, because otherwise this can be quite dangerous and people may die,” Dr. Andrew Monte, medical director at Rocky Mountain Poison & Drug Safety, told CBS News.
“Ibogaine has tremendous potential, but it’s really understudied at this time.”
Is ibogaine legal in the US?
Short answer: No.
Back in 1967, federal authorities classified ibogaine as a Schedule I controlled substance, placing it in the same category as heroin and LSD.
That designation is reserved for drugs the government says have no accepted medical use and a high potential for abuse.
It’s a major reason research into ibogaine has been so limited — though that may be starting to change.
Following Trump’s executive order, an investigational new drug clearance was issued for ibogaine, allowing it to be shipped to clinical investigators across state lines for research.
Federal agencies are also being directed to expand research, with funding allocated for clinical trials.
The first human clinical trial testing ibogaine that was approved by the FDA will look specifically at noribogaine hydrochloride, a derivative of ibogaine developed by drugmaker DemeRx NB, for the treatment of alcohol use disorder.
More than 29 million people in the US are affected by alcohol use disorder, which is a leading cause of preventable death nationwide.
